Argatroban labels and packages

Argatroban
Argatroban^® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Jesus Rosario Hernandez, M.D. [2]

Labels and Packages

Manufactured by: Cipla Ltd., India For: Eagle Pharmaceuticals, Inc. Woodcliff Lake, N.J. 07677

Marketed by: The Medicines Company Parsippany, N.J. 07054

THE MEDICINES COMPANY®

June 2011 Eagle Pharmaceuticals, Inc.

Principal Display Panel – Vial Label

NDC 42367-203-07 Rx Only

Argatroban

Injection

50 mg per 50 mL

(1 mg per mL)

Do not dilute

prior to administration

For Intravenous Infusion Only

Single Use Vial

Discard Unused Portion

Principal Display Panel – Carton Label

NDC 42367-203-07 Rx Only

Argatroban

Injection

50 mg per 50 mL

(1 mg per mL)

Do not dilute

prior to administration

For Intravenous Infusion Only

Single Use Vial

Discard Unused Portion

THE MEDICINES COMPANY®

Principal Display Panel – Box Label

NDC 42367-203-84 Rx Only

Argatroban

Injection

50 mg per 50 mL

(1 mg per mL)

10 Single Use Vials

For Intravenous Infusion Only

THE MEDICINES COMPANY®^[1]

Adapted from the FDA Package Insert.